P. Knowlesi Trial of Artesunate-mefloquine Versus Chloroquine

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Preliminary studies have supported the background efficacy of local standard anti-malarial medications in the treatment of uncomplicated knowlesi malaria, however this has not been tested systematically and there are no current WHO treatment guidelines for this infection. There are both health cost benefits to a more rapidly acting agent, and due to difficulties with microscopic identification there may be more effective treatment for all malaria species if an aligned treatment guideline could be supported. In addition, no therapeutic efficacy monitoring of current first line anti-malarials used for the treatment of P. vivax malaria have been conducted in Malaysia.

The investigators aim to test whether the fixed combination of artesunate-mefloquine is superior to chloroquine in order to define the optimal treatment for both uncomplicated P. knowlesi and P. vivax infection in both adults and children in this region.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Menzies School of Health Research
• Collaborator: Ministry of Health, Malaysia
• Treatments: Artemisinins; Artesunate; Chloroquine; Chloroquine diphosphate; Mefloquine; Primaquine

Criteria

Inclusion Criteria:

• Male and female patients at least 1 year of age and weighing more than 10kg

• Microscopic diagnosis of Plasmodium species infection

• Negative P. falciparum malaria rapid diagnostic test (histidine rich protein 2)

• Fever (temperature 37.5°C) or history of fever in the last 48 hours

• Able to participate in the trial and comply with the clinical trial protocol

• Written informed consent to participate in trial; thumbprint is required for illiterate patients, and written consent from parents/guardian for children below age of consent

Exclusion Criteria:

• Clinical or laboratory criteria for severe malaria, including warning signs, requiring parenteral treatment according to modified WHO criteria (see Appendix 4)

• Parasitaemia > 20,000 /μL (P. knowlesi)

• Inability to tolerate oral treatment

• Concomitant infection with any other malaria species

• Pregnancy or lactation

• Unable or unwilling to use contraception during study period

• Known hypersensitivity or allergy to artemisinin derivatives

• Serious underlying disease (cardiac, renal or hepatic)

• Received anti-malarials in last 2 months

• Previous psychiatric illness or epilepsy

• Previous episode of cerebral malaria